{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,4]],"date-time":"2026-04-04T22:28:43Z","timestamp":1775341723573,"version":"3.50.1"},"reference-count":25,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2024,8,6]],"date-time":"2024-08-06T00:00:00Z","timestamp":1722902400000},"content-version":"vor","delay-in-days":5,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100016348","name":"Kyowa Kirin Pharmaceutical Development","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100016348","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100016282","name":"MEI Pharma","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100016282","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["HemaSphere"],"published-print":{"date-parts":[[2024,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>In this global phase 2 study in patients with relapsed\/refractory follicular lymphoma (FL), zandelisib was administered on intermittent dosing to mitigate immune\u2010related adverse events and infections that have been reported with oral PI3K\u03b4 inhibitors administered daily continuously. Eligible patients with measurable disease and progression after at least two\u00a0prior therapies were administered zandelisib until disease progression or intolerability. The primary efficacy endpoint was objective response rate (ORR) and the key secondary efficacy endpoint was duration of response (DOR). We report on 121 patients with FL administered zandelisib on intermittent dosing after 8 weeks of daily dosing for tumor debulking. The median number of prior therapies was 3 (range, 2\u20138) and 45% of patients had refractory disease. The ORR was 73% (95% confidence interval [CI], 63.9\u201380.4), the complete response (CR) rate was 38% (95% CI, 29.3\u201347.3), and the median DOR was 16.4 months (95% CI, 9.5\u2013not reached). With a median follow\u2010up of 14.3 months (range, 1\u201330.5), the median progression\u2010free survival was 11.6 months (95% CI, 8.3\u2013not reached). Twenty\u2010one patients (17%) discontinued therapy due to an adverse event. Grade 3\u20134 class\u2010related toxicities included 6% diarrhea, 5% lung infections, 3% colitis (confirmed by biopsy or imaging), 3% rash, 2% AST elevation, and 1% non\u2010infectious pneumonitis. Zandelisib achieved a high rate of durable responses in heavily pretreated patients with relapsed\/refractory FL. The intermittent dosing resulted in a relatively low incidence of severe class\u2010related toxicities, which supports the evaluation of zandelisib as a single agent and in combination with indolent B\u2010cell malignancies.<\/jats:p>","DOI":"10.1002\/hem3.138","type":"journal-article","created":{"date-parts":[[2024,8,6]],"date-time":"2024-08-06T15:01:40Z","timestamp":1722956500000},"source":"Crossref","is-referenced-by-count":4,"title":["The PI3K\u03b4 inhibitor zandelisib on intermittent dosing in relapsed\/refractory follicular lymphoma: Results from a global phase 2 study"],"prefix":"10.1002","volume":"8","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1403-6883","authenticated-orcid":false,"given":"Andrew D.","family":"Zelenetz","sequence":"first","affiliation":[{"name":"Memorial Sloan Kettering Cancer Center New York New York USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wojciech","family":"Jurczak","sequence":"additional","affiliation":[{"name":"Maria Sklodowska\u2010Curie National Research Institute of Oncology Krakow Poland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vincent","family":"Ribrag","sequence":"additional","affiliation":[{"name":"Gustave Roussy Cancer Villejuif France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kim","family":"Linton","sequence":"additional","affiliation":[{"name":"The Christie NHS Foundation Trust and Manchester Cancer Research Centre Manchester UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Graham P.","family":"Collins","sequence":"additional","affiliation":[{"name":"GenesisCare Cancer and Radiotherapy Centre Oxford UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Javier L.","family":"Jim\u00e9nez","sequence":"additional","affiliation":[{"name":"University Hospital Ramon y Cajal Madrid Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark","family":"Bishton","sequence":"additional","affiliation":[{"name":"Translational Medical Sciences University of Nottingham and Nottingham University Hospitals NHS Trust Nottingham UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bhagirathbhai","family":"Dholaria","sequence":"additional","affiliation":[{"name":"Vanderbilt School of Medicine Nashville Tennessee USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrea","family":"Mengarelli","sequence":"additional","affiliation":[{"name":"IRCCS Regina Elena National Cancer Institute Rome Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tycel J.","family":"Phillips","sequence":"additional","affiliation":[{"name":"University of Michigan Health System Ann Arbor Michigan USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nagendraprasad","family":"Sungala","sequence":"additional","affiliation":[{"name":"Liverpool Hospital Sydney New South Wales Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gerardo","family":"Musuraca","sequence":"additional","affiliation":[{"name":"Istituto Scientifico Romagnolo per lo Studio et la Cura dei Tumori Meldola Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Oonagh","family":"Sheehy","sequence":"additional","affiliation":[{"name":"Belfast HSC Trust Belfast United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eric","family":"Van Den Neste","sequence":"additional","affiliation":[{"name":"Cliniques Universitaires Saint\u2010Luc Bruxelles Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mitsuhiko","family":"Odera","sequence":"additional","affiliation":[{"name":"Kyowa Kirin Co. Ltd. Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lu","family":"Miao","sequence":"additional","affiliation":[{"name":"MEI Pharma San Diego California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel P.","family":"Gold","sequence":"additional","affiliation":[{"name":"MEI Pharma San Diego California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Richard G.","family":"Ghalie","sequence":"additional","affiliation":[{"name":"MEI Pharma San Diego California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pier L.","family":"Zinzani","sequence":"additional","affiliation":[{"name":"IRCCS Azienda Ospedaliero\u2010Universitaria di Bologna Bologna Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,8,6]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1021\/acs.jmedchem.8b01298"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-11-1402"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.tibs.2005.02.008"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2017.75.4648"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.18.00915"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.20.03433"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1315226"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1314583"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(21)00145-5"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1158\/2326-6066.CIR-14-0095"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/hon.2540"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11523-019-00668-y"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinthera.2018.09.006"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2018.36.15_suppl.7519"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2018-99-115670"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/ijc.22617"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(22)00333-3"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2013.54.8800"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2022-159167"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2020-134869"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.2020008824"},{"key":"e_1_2_10_23_1","doi-asserted-by":"publisher","DOI":"10.1182\/bloodadvances.2020003170"},{"key":"e_1_2_10_24_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2022-157563"},{"key":"e_1_2_10_25_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(22)00200-5"},{"key":"e_1_2_10_26_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(22)00300-X"}],"container-title":["HemaSphere"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/hem3.138","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,8,27]],"date-time":"2024-08-27T13:30:13Z","timestamp":1724765413000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/hem3.138"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,8]]},"references-count":25,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2024,8]]}},"alternative-id":["10.1002\/hem3.138"],"URL":"https:\/\/doi.org\/10.1002\/hem3.138","archive":["Portico"],"relation":{},"ISSN":["2572-9241","2572-9241"],"issn-type":[{"value":"2572-9241","type":"print"},{"value":"2572-9241","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,8]]},"article-number":"e138"}}